CDC increases regulations after anthrax, smallpox scares

Jul. 11, 2014
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This 1975 file electronmicrograph from the Centers for Disease Control shows the smallpox virus. Government officials say workers cleaning a storage room at the National Institute of Health's campus in Maryland made a startling discovery last week of decades-old vials of smallpox forgotten in a cardboard box. / Uncredited AP

by Hoai-Tran Bui, USATODAY

by Hoai-Tran Bui, USATODAY

Following a string of public-safety scares, the Centers for Disease Control and Prevention will be shutting down two research labs, temporarily stopping all transfers of samples from high-level biosafety labs and strengthening its laboratory safety precautions, the CDC announced in a report Friday.

The new precautions came following an internal review of the CDC after three separate incidents of possible exposure to dangerous diseases at CDC labs and an FDA lab at the National Institutes of Health's Bethesda, Md., campus, all disclosed in the past three months. The latest, reported for the first time on Friday, involved the cross-contamination of an animal flu strain with a highly dangerous strain of bird flu.

CDC said its review found the three incidents were among a total of five cases of mishandled biological material over the past decade. One incident in 2006 occurred at the same lab where the recent problem with anthrax samples occurred.

"This is a wake-up call," CDC director Tom Frieden, said in a press conference Friday. "These events should never have happened, and they tell us we have to make significant improvements."

Frieden said that the CDC's priority after these incidents will be "improving the culture of laboratory safety."

"This will give all of us a heads up. If this can happen at the CDC, it can happen at any of our labs," said William Schaffner, professor of preventive medicine at Vanderbilt University Medical Center.

The CDC will be implementing a moratorium - or complete stop of the transfers of samples - on all biosafety level 3 and 4 labs, which contain the highest level of pathogenic samples, until all labs are fully assessed. Frieden said he has also appointed Michael Bell to the position of Director of Lab Safety, which will oversee a team of lab safety evaluators as well as look into the training of lab staff in appropriate procedures. Frieden said the CDC will also be taking disciplinary action against CDC staff who knowingly didn't follow protocol or report incidents.

"There are some major systematic issues we need to look at," Bell said.

Frieden said all three incidents are under investigation by the CDC and said that the two incidents that took place at CDC labs were a result of failures among CDC staff to follow standard operating procedure and oversight.

The CDC moratorium on shipment of highly dangerous germs will affect the federal agency's labs at its Atlanta headquarters and Fort Collins, Colo. The two Atlanta labs where the recent incidents occurred have been temporarily closed.

The most recent incident took place July 1, when several vials of smallpox were found unsecured in an NIH storage room in Bethesda, Md. On Friday, Frieden announced that tests show that two of the 60-year-old vials had live virus. More testing is going on, but all the samples are to be destroyed. No infections have been reported in that incident, either.

The first two incidents took place at CDC labs and involved the use of unapproved techniques to sterilize live samples of anthrax - potentially exposing other lab workers to live anthrax - as well as the cross-contamination of a low-pathogenic animal influenza strain with the highly dangerous H5N1 influenza in May. The CDC only learned of the incident Wednesday and disclosed the problem Friday.

Schaffner said it was clear there was no recombination of the two flu viruses into a mutated form. But even if there had been, the one strain infects animals and not people. The bird flu strain can be deadly, but is very hard to transmit to people, usually affecting those working with farm animals or taking care of a person infected with the H5N1 strain.

"So even if there had been a recombination event, it would not have been one that could have created a pandemic if it had escaped," Schaffner said.

The strain was supposedly contaminated at a CDC influenza lab before it was shipped to a lab at the U.S. Department of Agriculture, where lab workers discovered the contamination. The incident is still under investigation, but Frieden assured that there was no human exposure.

"This incident was the most distressing not because it's most dangerous," Frieden said, "â?¦ (But because) something like this could happen in a superb lab is unsettling. It's deeply troubling that there is an unacceptable delay in providing this information."

Frieden's disclosure of the third lab mishap was made in advance of a hearing Wednesday before an oversight subcommittee of the House Energy and Commerce committee, which has been investigating and raising concerns for years about the agency's history of lab safety and security incidents.

Despite CDC's reputation as operating some of one of the world's leading public health research laboratories, USA TODAY has previously reported on serious problems at CDC labs housing dangerous pathogens.

Usually private government audits obtained by USA TODAY last year, cited CDC for failing to ensure that those working with and around potential bioterror agents had received required training. In 2012, after obtaining internal agency e-mails, USA TODAY reported that a $214 million lab building on the agency's main campus had experienced repeated problems with important airflow systems designed to help prevent the release of infectious agents. The CDC has not responded to USA TODAY's requests under the Freedom of Information Act, filed in June 2012, for agency reports about safety, bio-containment and security concerns at the agency's labs. On Thursday, the CDC sent USA TODAY a letter saying it could not provide an estimate for when the records will be released.

Frieden assured that the CDC has undertaken serious measures to strengthen inspections and that the CDC will carefully review the recent incidents to strengthen the culture of lab safety.

"We have to stop, reassess and make sure events like this never happen in the future," Frieden said.